Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT00694135
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2008-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014606', 'term': 'Uveitis, Anterior'}], 'ancestors': [{'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'dispFirstSubmitDate': '2010-08-20', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-27', 'studyFirstSubmitDate': '2008-06-05', 'dispFirstSubmitQcDate': '2010-08-20', 'studyFirstSubmitQcDate': '2008-06-09', 'dispFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with an ACC score of zero at Days 14 and 28', 'timeFrame': 'Prospective study, subjects followed for 28 days', 'description': 'Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28'}], 'secondaryOutcomes': [{'measure': 'Time to ACC score of zero', 'timeFrame': 'Prospective study, subjects followed for 28 days', 'description': 'Time to anterior chamber cell score of zero'}, {'measure': 'Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28', 'timeFrame': 'Prospective study, subjects followed for 28 days', 'description': 'Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28'}, {'measure': 'Change from baseline in ACC score at Day 28', 'timeFrame': 'Prospective study, subjects followed for 28 days', 'description': 'Change from baseline in anterior chamber cell score at Day 28'}, {'measure': 'Treatment emergent adverse events', 'timeFrame': 'Prospective study, subjects followed for 28 days', 'description': 'Treatment emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iontophoresis', 'Non-Infectious Acute Anterior Segment Uveitis', 'Ophthalmology'], 'conditions': ['Uveitis, Anterior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.', 'detailedDescription': 'This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Non-infectious anterior uveitis\n\nExclusion Criteria:\n\n* Uveitis of infectious etiology\n* Previous anterior uveitis episode ≤ 4 weeks prior to baseline\n* Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications\n* Topical corticosteroid treatment in either eye \\< 48 hours prior to baseline\n* Oral corticosteroid or intraorbital corticosteroid treatment in either eye \\< 2 weeks prior to baseline\n* Active intermediate or posterior uveitis'}, 'identificationModule': {'nctId': 'NCT00694135', 'briefTitle': 'Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyegate Pharmaceuticals, Inc.'}, 'officialTitle': 'A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis', 'orgStudyIdInfo': {'id': 'EGP-437-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EGP-437 1.6 mA-min at 0.4 mA', 'description': 'Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA', 'interventionNames': ['Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EGP-437 4.8 mA-min at 1.2 mA', 'description': 'Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA', 'interventionNames': ['Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EGP-437 10.0 mA-min at 2.5 mA', 'description': 'Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA', 'interventionNames': ['Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EGP-437 14.0 mA-min at 3.5 mA', 'description': 'Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA', 'interventionNames': ['Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System']}], 'interventions': [{'name': 'EGP-437 1.6 mA-min at 0.4 with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Dexamethasone Phosphate Ophthalmic Solution'], 'description': 'Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['EGP-437 1.6 mA-min at 0.4 mA']}, {'name': 'EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Dexamethasone Phosphate Ophthalmic Solution'], 'description': 'Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['EGP-437 4.8 mA-min at 1.2 mA']}, {'name': 'EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Dexamethasone Phosphate Ophthalmic Solution'], 'description': 'Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['EGP-437 10.0 mA-min at 2.5 mA']}, {'name': 'EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System', 'type': 'DRUG', 'otherNames': ['Dexamethasone Phosphate Ophthalmic Solution'], 'description': 'Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System', 'armGroupLabels': ['EGP-437 14.0 mA-min at 3.5 mA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02142', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye Research and Surgery Institution', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Comprehensive Eye Care Ltd.', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye & Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Services University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19027', 'city': 'Elkins Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania College of Optometry', 'geoPoint': {'lat': 40.07706, 'lon': -75.12684}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institue', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southern College of Optometry', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '560 037', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'St. Johns Medical College and Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560 037', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Vittala International Institute of Ophthalmology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560010', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Narayana Nethralaya', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '580 021', 'city': 'Hubli', 'state': 'Karnataka', 'country': 'India', 'facility': 'M. M. Joshi Eye Institute', 'geoPoint': {'lat': 17.58662, 'lon': 76.51148}}, {'zip': '576104', 'city': 'Manipal', 'state': 'Karnataka', 'country': 'India', 'facility': 'Kasturba Medical College and Hospital', 'geoPoint': {'lat': 13.35, 'lon': 74.78333}}, {'zip': '632011', 'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Christian Medical College', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}], 'overallOfficials': [{'name': 'C. Stephen Foster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye Research and Surgery Institution'}, {'name': 'Michael Raizman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyegate Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Stephen From, President and Chief Executive Officer', 'oldOrganization': 'Eyegate Pharmaceuticals, Inc.'}}}}